(81 days)
Transtek Blood Pressure Monitor LS802-E is a digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).
This device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, LS802-E is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Blood Pressure Monitor, LS802-E is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.
Measurement method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".
Transtek Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22cm and 42 cm. includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the purnp, the electromagnetic deflation control valve and the LCD. The subject device is powered by four AA alkaline batteries or by a DC 6V 400mA adapter.
The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.
Transtek Blood Pressure Monitor LS802-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement data from LS802-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
The provided text describes a 510(k) premarket notification for the TRANSTEK Blood Pressure Monitor, Model LS802-E. This submission focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Blood Pressure Monitor, Model LS-802, K120058), particularly highlighting an added wireless data communication function and a change in cuff surface materials.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO14971 (Risk Management) | Conforms to the standard |
| AAMI/ANSI SP10 (Safety and performance characteristics) | Conforms to the standard |
| IEC60601-1 (Electrical safety) | Conforms to the standard |
| IEC60601-1-2 (Electromagnetic compatibility) | Conforms to the standard |
| ISO10993 (Biological evaluation of medical devices) | Conforms to the standard |
| FCC Part 15 (EMI tests of FCC Radiation & RF rules and regulations) | Conforms to the standard |
| FDA guidance document "Non-Invasive Blood Pressure (NiBP) Monitor Guidance" FDA March 10, 1997 | All applicable performance tests have been done in accordance with demands of this guidance document. |
Note: The document explicitly states, "The new wireless function does not affect blood pressure monitor measurement function. Therefore we have not done the Clinical test." This indicates that the core blood pressure measurement performance, which would typically involve clinical validation against acceptance criteria for accuracy (e.g., AAMI/ANSI SP10 for blood pressure accuracy), was not re-evaluated clinically for this specific submission because the change was deemed not to impact the measurement function. The substantial equivalence relies on the predicate device's prior clinical validation for blood pressure accuracy.
2. Sample Sizes and Data Provenance
- Test Set (Clinical Data for Blood Pressure Accuracy): Not applicable for this specific submission. The document explicitly states that no clinical test was performed due to the nature of the modifications (wireless function and cuff material). The clinical performance data for blood pressure accuracy would have been established for the predicate device (K120058). The document does not provide details on the sample size or data provenance for the predicate device's clinical validation.
- Other Performance Tests (Bench Tests): "Bench tests have been done" for design control activities, risk management, and design verification tests. No specific sample sizes for these bench tests are mentioned. Data provenance is implied to be from the manufacturer's internal testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, ground truth would typically be established by trained professionals using a reference method (e.g., auscultation by multiple observers). However, no details are provided for the predicate device's study.
4. Adjudication Method (Test Set)
- Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, a common adjudication method for clinical studies would involve multiple observers (e.g., two observers with a third to adjudicate discrepancies). No details are provided for the predicate device's study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically for AI-assisted diagnostic devices to measure the improvement in human reader performance. The device here is a blood pressure monitor, and the changes are related to wireless transmission and cuff material, not AI-assisted interpretation.
6. Standalone (Algorithm Only) Performance Study
- A standalone study for the blood pressure measurement algorithm was implicitly done for the predicate device to establish its accuracy. However, for this submission (LS802-E), because the core measurement algorithm was unchanged, a new standalone study was not performed. The new elements (wireless and cuff material) do not involve an "algorithm only" performance that would typically be evaluated in a standalone study for diagnostic AI.
7. Type of Ground Truth Used (Test Set)
- Not applicable for a clinical test in this submission. For the predicate device's blood pressure accuracy validation, the ground truth would have been based on reference blood pressure measurements, typically performed by trained operators using a validated method (e.g., auscultation with a mercury sphygmomanometer).
8. Sample Size for the Training Set
- Not applicable. This device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense for diagnostic image analysis or similar applications. The device uses the "oscillometric method" which is a well-known, established technique based on signal analysis, not a learned model from a large training dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for a machine learning model.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).